CLINICAL EVALUATION OF NESTORONE/ESTRADIOL-RELEASING VAGINAL RING FOR FEMALE CONT
CLINICAL EVALUATION OF NESTORONE/ESTRADIOL-RELEASING VAGINAL RING FOR FEMALE CONT
批准号:
8261623
负责人:
DAVID ARCHER
金额:
$51.14万
依托单位国家:
美国
项目类别:
财政年份:
2011
资助国家:
美国
项目状态:
已结题
起止时间:
2011-03-31 至 2013-03-31
关键词:
Adverse effectsAdvisory CommitteesAgeClinicalClinical TrialsClinical Trials NetworkConduct Clinical TrialsConsultationsContraceptive AgentsContraceptive methodsContractorContractsDataDevelopmentDevicesDoseDrug KineticsEnrollmentEstradiolFemaleFemale Contraceptive AgentsGoalsGynecologicHemorrhageHuman ResourcesInterventionMale Contraceptive AgentsMethodsMissionNational Institute of Child Health and Human DevelopmentNestoroneNotificationObesityPatternPharmaceutical PreparationsPhasePopulationPrincipal InvestigatorProgestinsProtocols documentationPublic HealthRandomizedResearchResearch DesignRiskRisk FactorsSafetySiteSpecific qualifier valueThromboembolismVaginal RingVenousWomanabstractingbasecontraceptive effectivenesscontraceptive efficacydrug candidateprogramsprotocol developmentreproductiveresearch clinical testingtreatment trialunintended pregnancy
中文摘要
摘要:NICHD的避孕临床试验网络开展了各种新型女性和男性避孕方法的I、II和III期临床试验。该合同的目的是让CCTN承包商进行女性避孕临床试验,进行妇科疾病的治疗试验,并根据不确定交付/不确定数量(IDIQ)合同在任务订单的基础上制定研究方案。
英文摘要
Abstract: The NICHD's Contraceptive Clinical Trials network conducts Phase I, II and III clinical trials of a wide variety of new female and male contraceptive methods. The objective of this contract is for CCTN contractors to conduct female contraceptive clinical trials, conduct treatment trials of gynecologic conditions, and to develop research protocols on a task Order basis under an Indefinite Delivery/Indefinite Quantity (IDIQ) contract.
There is a demand for new methods of contraception that can provide effective protection against unintended pregnancy as well as reduce the risk of venous thromboembolism (VTE), particularly for obese women. A new vaginal ring that can deliver a high dose progestin (Nestorone) and a low dose of estradiol (E2) may provide effective and safe contraception for women. The objective of the dose finding study is to identify a dose that can provide reliable contraception and acceptable bleeding patterns for up to 6 months of use.
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会议论文
CONTRACEPTIVE CLINICAL TRIALS NETWORK, CCTN - FEMALE SITES 'CORE FUNCTION ACTIVITIES
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批准号:10891324
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项目类别:
-
资助金额:$0.11万
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财政年份:2020
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负责人:DAVID ARCHER
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依托单位:
CONTRACEPTIVE CLINICAL TRIALS NETWORK, CCTN - FEMALE SITES 'CORE FUNCTION ACTIVITIES
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批准号:10245985
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项目类别:
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资助金额:$0.71万
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财政年份:2020
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负责人:DAVID ARCHER
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依托单位:
CCTN-PHARMACOKINETIC/PHARMACODYNAMIC EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION
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批准号:10497856
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项目类别:
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资助金额:$25.87万
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财政年份:2018
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负责人:DAVID ARCHER
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依托单位:
CCTN - CONTRACEPTIVE CLINICAL TRIAL NETWORK - FEMALE SITES
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批准号:9150719
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项目类别:
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资助金额:$30.96万
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财政年份:2015
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负责人:DAVID ARCHER
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依托单位:
CLINICAL EVALUATION OF LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION
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批准号:8331709
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项目类别:
-
资助金额:$9.58万
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财政年份:2011
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负责人:DAVID ARCHER
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依托单位:
CONTRACEPTIVE EFFICACY EVALUATION OF THE PATH FEMALE CONDOM
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批准号:7947248
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项目类别:
-
资助金额:$19.42万
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财政年份:2009
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负责人:DAVID ARCHER
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依托单位:
PHASE II STUDY TO COMPARE CDB-2914 AND LEVONORGESTREL
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批准号:6348785
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项目类别:
-
资助金额:$14.55万
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财政年份:1999
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负责人:DAVID ARCHER
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依托单位:
PHASE II STUDY TO COMPARE CDB-2914 AND LEVONORGESTREL
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批准号:6140133
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项目类别:
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资助金额:$0.0万
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财政年份:1999
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负责人:DAVID ARCHER
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依托单位:
PHASE II STUDY TO COMPARE CDB-2914 AND LEVONORGESTREL
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批准号:6096460
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项目类别:
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资助金额:$15.69万
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财政年份:1999
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负责人:DAVID ARCHER
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依托单位:
FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -2753382I
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批准号:6994788
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:DAVID ARCHER
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依托单位:
FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -275003382
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批准号:7191397
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:DAVID ARCHER
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依托单位:
FEMALE CONTRACEPTIVE CLINICAL TRIAL: A RANDOMIZED CONTROLLED STUDY OF -275003382
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批准号:7329615
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项目类别:
-
资助金额:$0.0万
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财政年份:--
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负责人:DAVID ARCHER
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依托单位:
海外基金